COMPOSITION
GANCIGEL™ contains Ganciclovir 0.15% in a Sterile Ophthalmic Gel Base.

INDICATIONS AND USAGE
GANCIGEL™ (ganciclovir ophthalmic gel) 0.15% is a topical ophthalmic antiviral that is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

PHARMACOLOGY/ PHARMACOKINETICS
Ganciclovir is activated to ganciclovir triphosphate by viral and cellular thymidine kinases (TK).  This active metabolite then inhibits DNA replication by competitive inhibition and direct incorporation into viral DNA resulting in chain termination.  Ganciclovir has activity against Epstein-Barr virus, cytomegalovirus (CMV), adenovirus, herpes zoster and herpes simplex virus (HSV) types 1 and 2.

Ganciclovir ophthalmic gel has minimal systemic absorption with the total daily topical dose approximately 0.04% and 0.1% of oral and intravenous ganciclovir doses, respectively. Due to minimal systemic exposure systemic pharmacokinetics will not be discussed.

DOSAGE AND ADMINISTRATION
The recommended dosing regimen for GANCIGEL™ is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

DOSAGE FORMS AND STRENGTHS
GANCIGEL™ contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.

PREGNANCY –  Pregnancy Category C.

LACTATION – No information available

CONTRAINDICATIONS
None.

WARNINGS AND PRECAUTIONS
• GANCIGEL™ is indicated for topical ophthalmic use only.

• Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with GANCIGEL™.

ADVERSE REACTIONS
Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

PRESENTATION
Available in 5 g Aluminium Collapsible Tube

STORAGE
Store in dry, well ventilated place at a temperature not exceeding 30°C. Do not freeze

 

Disclaimer: Any product related information is intended for medical practitioners only